跳至主要内容
临床试验/NCT00655161
NCT00655161已完成2 期

A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation

GlobeImmune1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Immune response to GI-4000

研究概览

简要总结

This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.

详细描述

NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in the United States. The best treatment for NSCLC is surgical resection. For patients with inoperable or unresectable NSCLC chemotherapy and radiation is used as first line therapy. This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment. These subjects must also have a ras mutation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically proven stage I-III NSCLC
  • Confirmed product related ras mutation
  • ECOG performance status of less than or equal to 2
  • greater than or equal to 18 years of age

排除标准

  • History of a previous cancer
  • History of splenectomy
  • History of Crohns disease or ulcerative colitis
  • History of major organ transplantation
  • Concurrent or chronic steroid therapy
  • History of allergy to yeast
  • Presence of an unstable or poorly controlled medical condition
  • Pregnant or nursing mothers
  • Positive skin test to yeast

结局指标

主要结局

Immune response to GI-4000

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
GlobeImmune
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验